Infliximab concentrations in two non-switching cohorts of patients with inflammatory bowel disease: originator vs. biosimilar

Biosimilars are replacing originator compounds due to their similar effectiveness, safety and pharmacokinetics. Our objective was to compare the differences in pharmacokinetics and clinical outcomes between the originator infliximab (Ifx) and the biosimilar CT-P13 in a patient cohort with inflammato...

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Bibliographic Details
Published in:Scientific reports 2020-10, Vol.10 (1), p.17099, Article 17099
Main Authors: Martínez-Feito, Ana, Bravo-Gallego, Luz Yadira, Hernández-Breijo, Borja, Diez, Jesús, García-Ramirez, Laura, Jaquotot, Marta, Plasencia-Rodríguez, Chamaida, Nozal, Pilar, Mezcua, Araceli, Martín- Arranz, María Dolores, Pascual-Salcedo, Dora
Format: Article
Language:English
Subjects:
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631/250/251
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Adolescent
Adult
Antibodies, Monoclonal - blood
Antibodies, Monoclonal - pharmacokinetics
Antibodies, Monoclonal - therapeutic use
Biomarkers - blood
Biosimilar Pharmaceuticals - blood
Biosimilar Pharmaceuticals - pharmacokinetics
Biosimilar Pharmaceuticals - therapeutic use
Female
Humanities and Social Sciences
Humans
Inflammatory Bowel Diseases - blood
Inflammatory Bowel Diseases - drug therapy
Infliximab - blood
Infliximab - pharmacokinetics
Infliximab - therapeutic use
Male
Middle Aged
multidisciplinary
Retrospective Studies
Science
Science (multidisciplinary)
Treatment Outcome
Young Adult
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Summary:Biosimilars are replacing originator compounds due to their similar effectiveness, safety and pharmacokinetics. Our objective was to compare the differences in pharmacokinetics and clinical outcomes between the originator infliximab (Ifx) and the biosimilar CT-P13 in a patient cohort with inflammatory bowel disease (IBD). Our cohort study included 86 patients from a historical and a prospective cohort from the start of infliximab treatment to 22 weeks later. Serum infliximab, antidrug antibody levels and other serum biomarkers were measured at weeks 0, 2, 6, 14 and 22. Remission outcomes were evaluated at weeks 14 and 22. Drug levels were measured prospectively and analysed using MANOVA. Of the 86 patients, 44 (51%) and 42 (49%) were administered the originator and CT-P13, respectively. Originator trough levels were higher than the biosimilar trough levels (35 vs. 21, 20.1 vs. 11, 6.6 vs. 2.9 and 4.3 vs. 1.7 μg/mL at weeks 2, 6, 14 and 22, respectively). A post-hoc analysis demonstrated changes in mean serum drug levels over time (p 
ISSN:2045-2322
2045-2322
DOI:10.1038/s41598-020-74235-1